Recently, while on a monitoring visit for a physician sponsored IDE study in which IMARC was concurrently conducting a clinical audit, I was caught off guard by the question “do you know what the FDA Form 3674 is?” I thought I had spent a good deal of my professional career working in the clinical research industry, I try my best to be a diligent student of the regulations and GCP guidelines, and even have tested my wits by passing the SOCRA certified clinical research professional exam. However, I was stumped when it came to this mysterious form, albeit somewhat relieved that my co-monitor and the auditor that asked me were equally baffled by what it was. At our auditor’s good suggestion, we took to finding the answer. That night, she emailed FDAs FDAs [email protected] for their input. This is really a fantastic tool in and of itself if you have not utilized it, someone from FDA will respond to your questions regarding good clinical practice in the field of clinical research.
Topics: 510(k) Program, Clinical Auditing, FDA, Form 3674
